Duns Number:051334402
Device Description: DASH Pod
Catalog Number
-
Brand Name
Omnipod DASH Pod
Version/Model Number
POD-BLE-11-520
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180045,K180045,K180045,K180045
Product Code
LZG
Product Code Name
Pump, Infusion, Insulin
Public Device Record Key
9c3a70fa-e8a8-4ee0-8c96-000616ba7246
Public Version Date
September 12, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2018
Package DI Number
20385082000020
Quantity per Package
10
Contains DI Package
10385082000023
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10 Pack Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |